Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Toxicology ×
3,029 results
385–408 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared May 30, 2008
RAPID TOX CUP
K073078 · LAG
American Bio Medica Corp.
Toxicology · 212d
Cleared Apr 30, 2008
MAS TOX CONTROL
K080085 · DIF
Thermo Fisher Scientific
Toxicology · 110d
Cleared Apr 28, 2008
RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA
K071867 · ODV
Paragondx, LLC
Toxicology · 297d
Cleared Mar 28, 2008
HOMECHECK MULTIPLE DRUG CUP TEST
K071489 · DKZ
Tianjin New Bay Bioresearch Co., Ltd.
Toxicology · 303d
Cleared Mar 21, 2008
COBAS LITHIUM
K063684 · NDW
Roche Diagnostics Corp.
Toxicology · 465d
Cleared Mar 19, 2008
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS:...
K072036 · LEH
Biokit, S.A.
Toxicology · 238d
Cleared Jan 30, 2008
MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL
K072257 · LAS
More Diagnostics
Toxicology · 170d
Cleared Jan 23, 2008
INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN
K073014 · ODW
Autogenomics, Incorporated
Toxicology · 90d
Cleared Jan 07, 2008
REDLINE ALCOHOL BREATH TESTER
K072953 · DJZ
Redline Products (Pty) , Ltd.
Toxicology · 81d
Cleared Dec 07, 2007
AT HOME DRUG TEST MODELS, 9308T AND 9308X
K070009 · DIS
Phamatech, Inc.
Toxicology · 338d
Cleared Dec 07, 2007
QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018
K070098 · DIS
Phamatech, Inc.
Toxicology · 331d
Cleared Nov 26, 2007
MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP
K062575 · LAG
Princeton BioMeditech Corp.
Toxicology · 452d
Cleared Oct 17, 2007
PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
K063145 · DIP
Thermo Electron OY
Toxicology · 366d
Cleared Oct 09, 2007
LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM...
K063705 · NDW
Thermo Electron OY
Toxicology · 300d
Cleared Oct 05, 2007
CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
K063131 · KLT
Thermo Electron OY
Toxicology · 357d
Cleared Sep 28, 2007
ARCHITECT SIROLIMUS ASSAY
K070822 · NRP
Fujirebio Diagnostics,Inc.
Toxicology · 186d
Cleared Sep 20, 2007
UCP MULTIPLE DRUG SCREEN TEST CUPS
K072062 · LFG
Ucp Biosciences, Inc.
Toxicology · 55d
Cleared Sep 17, 2007
VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
K070804 · ODW
Nanosphere, Inc.
Toxicology · 178d
Cleared Sep 12, 2007
ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620
K071644 · DLZ
Roche Diagnostics Corp.
Toxicology · 89d
Cleared Aug 24, 2007
ETOH FLEX REAGENT CARTRIDGE (DF22)
K071811 · DIC
Dade Behring, Inc.
Toxicology · 52d
Cleared Aug 02, 2007
SENTINEL LITHIUM ASSAY
K070987 · NDW
SENTINEL CH. SpA
Toxicology · 118d
Cleared Aug 01, 2007
ARCHITECT TACROLIMUS: MODEL 1L77
K070820 · MLM
Fujirebio Diagnostics,Inc.
Toxicology · 128d
Cleared Jun 08, 2007
ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)
K070810 · LGS
Biokit, S.A.
Toxicology · 74d
Cleared May 25, 2007
MASSTRAK IMMUNOSUPPRESSANTS KIT
K063868 · MLM
Waters Corporation
Toxicology · 147d